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HEALTH Law Concerning ~ Medical Devices Is Often Ignored By THOMas M. BoxTOv StaJJReporter of Tx€ Wwt.t. Srnt:eT JOURNAL Although hospitals and doctors are le- gally required to disclose malfunctions of heart valves, wheelchair lifts and other medical equipment, in fact, many don't. More than three years after the pas- sage of the Safe Medical Devices Act, the Food and Dru Administration still hasn't is ue a regulation c ar ing which health-care providers have to disclose what information. "The lack of a final regulation has caused a great deal of confusion," acknowledges Bryan H. Ben- esch, an FDA official who helps oversee enforcement of the medical-device report- ing laws. "Many people just don't under- stand what they're supposed to do." Says another FDA official, "We're aware that people will thumb their noses at us until there is a regulation." Manufacturers of medical devices have been required to report problems with medical devices since 1985. But scores of them haven't done it. In the late 1980s, dozens of babies hooked up to "apnea" monitors, which sense breathing and ~ heartbeats, died in their sleep, including cases in which the monitors reportedly failed to sound an alarm. One manufac- turer, Aequitron Medical Inc. of Minneapo- lis, didn't notify the FDA of more than 50 deaths, according to congressional testi- mony; Aequitron says it has since re- vamped its machines and reporting pol- icy. Between 1988 and 1991, FDA inspectors found that 65 companies hadn't reported serious incidents. The agency says compa- nies failing to report included indus- try leaders like C.R. Bard Inc., which didn't report 229 incidents involving its cardiac angioplasty catheters, and Eli Lilly. & Co.'s Cardiac Pacemakers Inc. unit, which didn't disclose more than 600 patient problems related to its insulin infusion pump. Bard declines to comment. Cardiac Pacemakers, which discontinued sale of the pump, says it hadn't believed the incidents needed to be reported. Because the manufacturers couldn't be counted on to report problems with their devices, the new law, passed in 1990, put additional responsibility for reporting in the hands of hospitals and doctors. But in February, the General Accounting Office, Congress's investigative arm, said in a letter to Rep. John Dingeil that the FDA had found evidence that hospitals and ~ther health providers were largely disre garding the law. For example, the Colorado Department of Health reported to the FDA that it visited 175 health-care facilities and found that only 36% of them were fully complying and that only 26% of personnel understood what Please Tunt to Page B6, Column 1 Law on Medical Device Problems Is Frequently Ignored by Hospitals Continued Fronc Page BI the law requires. In Texas, about 45% of the 175 facilities surveyed were~ aware of the act, and 35% of them had written proce- dures telling staffers specifically what to do. Only in a Massachusetts survey did compliance seem better, with 72% of the 118 facilities surveyed being aware of the act's reporting requirements. Reporting problems is often the only early warning signal that something is wrong with a medical device. Because many devices have been grandfathered onto the market, they have not undergone rigorous scrutiny. Breast implants are a well-known example. They have been ten- tatively linked to immune-system illnesses and definitively linked to painful and dis- figuring conditions, including open sores through which silicone seeps out. When FDA inspectors making routine visits turn up evidence that companies have failed to make required disclosures, the agency responds with warning letters Wall St. Jnl Washington, DC MAY 7 i 1gq~ and other regulatory sanctions, says FDA Commissioner David Kessler, who believes these measures are improving compliance with the reporting law. The total number of reports of malfunctions and related deaths and injuries jumped to 88,265 by 1993 from 27,883 in 1990. Even so, FDA officials believe there is still underreporting - "the magnitude ... is anybody's guess," Mr. Benesch says. When manufacturers do file reports, he adds, there often is no corresponding re- ~ port filed by a hospital. The underreporting by manufacturers was especially egregious in the first few years of the law. In a December 1986 survey of hospitals, the GAO concluded that 99,70 of problems associated with cer- tain selected medical devices weren't re- ported. ---- To Bruce A. Finzen, a Minneapolis products-liability lawyer, congressional attempts to fix problems like underreport- ing just aren't very effective. "The device- reporting law just sits there," he says. ~'